This section describes how to implement CDISC standards for the collection, representation, and exchange of tobacco product study data. Implementation of standards described in this section support use cases for data inherent to studies of tobacco products. Use cases selected are comprised of concepts identified by one or more stakeholders as important in the context of tobacco product studies and fall in the following four categories:
| Metadataspec |
|---|
| Category | Description |
|---|
| Product Description |
Product Description, for data which Data to characterize a product. |
Trial Design, for data which | Trail Design | Data to describe the design of a study. | | Nonclinical |
, for data | Data from in vitro and in vivo nonclinical studies. | | Product Impact on Individual Health |
, for data | Data to assess the impact on of a product on |
individuals | individuals. | | Product Impact on Population Health |
, for data | Data to assess the impact of a product on a population of individuals |
Trail Design | Nonclinical | Product Impact on Individual Health | Product Impact on Population Health |
Guidance in this section is organized in the following sections:
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